A Covid-19 vaccine candidate developed by Pfizer and BioNTech was found to be more than 90 percent effective in preventing the Covid-19 in participants without evidence of prior infection of the viral respiratory disease.

The developers announced the results on Monday, November 09, 2020, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.

They said that their study enrolled 43,538 participants, with 42 per cent having diverse backgrounds, and no serious safety concerns have been observed; but added that safety and additional efficacy data continue to be collected.

This is the first time a vaccine against Covid-19 has reached such level without any serious safety concerns.

Dr. Félix Sayinzoga, a Maternal, Child and Community Health Division Manager at the Rwanda Biomedical Centre (RBC) told The New Times that the move is a good step in Covid-19 vaccine development. 

"The study is not yet conclusive and is still ongoing and the vaccine efficacy may vary but it is promising, looking at the preliminary results,” he said.

But, organisations that fight the injustice of poverty, such as Oxfam International, have warned that the promising vaccine should not be a preserve of the developed countries.

Implications of findings

The medical breakthrough comes as the world is grappling with the Covid-19 pandemic that has claimed many lives destabilised the world’s economy and caused a decline in the fortunes of travel and tourism industry over safety concerns.

A tally by the Johns Hopkins University’s Coronavirus Resource Center indicates that global Covid-19 cases were over 50.9 million, while deaths amounted to over 1,263,000 as of Tuesday, November 10, 2020.

In response to the results, Niko Lusiani, Senior Advisor with Oxfam America made a statement indicating that "Pfizer and BioNTech’s encouraging results bring us all hope that we can get out of our current pandemic nightmare, but that simply won’t happen unless the vaccine is available and affordable to everyone.”

Speaking to The New Times, Dr Menelas Nkeshimana, Team Lead for Covid-19 Case Management and Coordinator for the Western Province said that the ideal is to have a vaccine that can be 100 percent effective in preventing diseases, something he said can hardly ever be achieved.

"If a vaccine has a 90 percent efficacy in protecting you from a disease, it means that it can protect 9 in 10 people who received it, which is really a high rate, a spectacular performance” he said.

"It is laudable because it enables people to return to normal life, and ease travels as people will have got an effective vaccine to protect them,” he said, pointing out that it is better than a face mask as it cannot assure one of such level of protection.

Call for affordability, equitable access

However, Lusiani said that "Pfizer’s estimated price for the vaccine is too high and the company cannot produce enough. The vaccine will be 0% effective to the people who can’t access or afford it."

In the US, the companies have priced the vaccine at $19.5 per dose, or approximately $40 per two-dose regimen, for its [first] 100 million dose order.

Meanwhile, Lusiani said, rich countries are hoarding more than half of the vaccines developed by the companies with the leading five vaccine candidates, indicating that the US, with only 4 percent of the world’s population, has already called dibs on almost 50 percent of Pfizer’s total expected supply in 2021.

"To protect everyone no matter their wealth or nationality, Pfizer and BioNTech must commit to openly sharing their vaccine technology to enable billions of doses to be made now at the lowest possible price,” he observed.

On how countries like Rwanda could get the vaccine, Dr. Nkeshimana said that it will require measures that ensure its equitable distribution.

"The World Health Organization will have to do something that is like imposing conditions on manufacturers to agree to supply the vaccine to different countries in need before it gets a licence,” he said.

RBC’s Dr. Sayinzoga noted that there are many vaccines under trial that have reached different stages and depending on their types, it is not easy to say when the effective vaccine may reach Rwanda or other countries.

"But according to the COVAX facility, countries may expect the vaccines between January and June 2021 (first shipment),” he said.

"Rwanda as part of the COVAX Facility is ensured to have sufficient doses for protecting vulnerable people, health workers and other on the frontline,” he said, explaining that vulnerable people referred to here are those with medical conditions that can complicate their situation, and those with 65 years and above.

The COVAX Facility is an umbrella mechanism through which demand and resources are pooled to support procurement of, and equitable access to, Covid-19 vaccines. It is co-led by Global Alliance for Vaccines and Immunisation (GAVI), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO).

It is part of the Access to COVID-19 Tools (ACT) Accelerator which was launched in April 2020 to speed up development and delivery to countries of diagnostics, treatments, and vaccines. It includes a health systems connector to support the delivery of these resources to countries.

The ACT Accelerator aims to deliver two billion vaccine doses for global needs by the end of 2021.

The Vaccine allocation will be driven by public health needs for priority groups, which may represent about 20 percent of the population, in the first year.

The WHO recommends front-line personnel (such as health workers) and seniors be the first priority to receive vaccine.

Vaccine testing and approval process

According to the WHO, the following actions are taken to ensure a new vaccine is safe and works well are:

• Pre-clinical studies

In this stage, a vaccine is tested in animal studies for efficacy and safety, including challenge studies

• Phase I clinical trial

According to the WHO, when candidate vaccines make it to human clinical trials, they first go through Phase 1 trials primarily to test the vaccine’s safety, determine dosages and identify any potential side effects in a small number of people.

 Small groups of healthy adult volunteers receive the vaccine to test for safety.

• Phase II clinical trial

A vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended to further explore safety and start to investigate efficacy on larger groups.

 • Phase III clinical trial

WHO says that the final stage, Phase 3 trials, which few vaccines ever make it to, are much larger, involving thousands or tens of thousands of people, to confirm and assess the effectiveness of the vaccine and test whether there are any rare side effects that only show up in large groups.